ThermAffyx(TM) Patient Safety System
FDA 510(k) K260278 · Stihler Electronic GmbH
510(k) numberK260278
Submission
- Device name
- ThermAffyx(TM) Patient Safety System
- Applicant
- Stihler Electronic GmbH
Leinfelden-Echterdingen, DE - Received
- January 29, 2026
- Decision date
- July 8, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWJ – System, Thermal Regulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was ThermAffyx(TM) Patient Safety System cleared by the FDA?
ThermAffyx(TM) Patient Safety System (K260278) received a 510(k) decision of Substantially Equivalent on July 8, 2026, 160 days after the submission was received.
What is the product code of K260278?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.